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7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSE US Connect 2019 Baltimore, MD

7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

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Page 1: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

7 Habits of Highly Effective (Validation Issue) Managers

Amy GarrettPhUSE US Connect 2019

Baltimore, MD

Page 2: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Validation Issues

• Validation report identifies areas of non-compliance• 100s of issues

• Review of validation report is manual• Time to review a report is varied

• Why are some people faster than others?• Room for process ?

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Page 3: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

The 7 Habits

1. Validates early 2. Gathers all relevant info about issues 3. Identifies the source(s) of issues 4. Tracks changes between validation reports 5. Communicates issues to others 6. Knows when to fix validation issues 7. Knows when to explain validation issues

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Page 4: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit One Validate Early

• Leverage validation tools to find mistakes before a programmer does• Programming errors• Mapping spec errors

• Saving Time = Saving $$$• It’s trendy

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Page 5: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Two Gather All (relevant) Info About Issues

• Efficiently look into the data for more details about an issue –sometimes even all the way back to EDC• Validator Tools – Pinnacle 21 Enterprise provides more details than

Community• SAS Macros - The Devil is in the Details – Reporting from Pinnacle 21

Validation Report (Garrett and Whalen, 2015). • Challenging trace all the way back EDC

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Page 6: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Three Identify the Source(s) of Issues

• Knowing the sources of issues can help discover patterns and data quality gaps.• Assign a source to an issue directly in Excel• P21E supports issue tags (source) to help group issues • Too often, a source is not captured and only comments are entered which limits the ability to

improve your process.

• Most issues fall into one or more of the categories:• Data collection error• Programming/spec error• Metadata (define.xml) • Sponsor-defined addition• Study is ongoing• False positive

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Page 7: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Four Track Changes Between Validation Reports

• Three types of issue changes to track• New issues • Resolved issues• Updated issues

• Proc Compare ?• Pinnacle Comparison Functionality

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Page 8: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Five Communicates Issues to Others

• Validation Report is often distributed to users but issues often need to be translated for stakeholders. Each issue should contain information about: • Why did this issue happen? (source)• Who is responsible for fixing it?• Supporting details• Issue Explanation (if applicable)

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Page 9: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Six Knows When & How to Fix Validation Issues

• Some issues resolve over time• Variable length is longer than max length of data• Start date is after last disposition date

• Some issue should be fixed• Issues related to data collection• Issues related to define.xml (DD and OD prefix)

• Some issues MUST be fixed• PMDA: Reject issues • FDA: Reject and High Impact issues

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Page 10: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Six Knows When & How to Fix Validation Issues

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Page 11: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Six Knows When & How to Fix Validation Issues

• How can any one person know how to fix all the possible issues ?• Experience• Common Pinnacle 21 Report Issues: Shall we Document or Fix (Gupta, 2018)• Pinnacle 21 Fix Tips

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Page 12: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Seven Knows How to Explain Validation Issues

• Any issue that remains must be explained• Consistent explanations across studies for the same issues – only data specific

details should change• Best Practice for Explaining Validation Results in the Study Data (Kelly, 2018)

• How to implement best practices?• Internal master document of Issue Explanations• Manage them in a different system

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Page 13: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Habit Seven Knows How to Explain Validation Issues

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Page 14: 7 Habits of Highly Effective (Validation Issue) Managers · 7 Habits of Highly Effective (Validation Issue) Managers Amy Garrett PhUSEUS Connect 2019 Baltimore, MD

Thank You! Questions?

Amy Garrett

[email protected]

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